AzTrials
AzTrials

Postpartum DepressionNCT04485000

Online 1-Day CBT-Based Workshops for PPD

A study testing Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop in people with Postpartum Depression, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Postpartum depression (PPD) already affects up to 1 in 5 women and left untreated costs $150,000 per case over the lifespan. Under normal conditions, just 10% of women with PPD get evidence-based treatment, a situation that has worsened substantially during COVID-19. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Postpartum Depression
What is being tested?
Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop
Could I receive a placebo?
No, everyone receives an active treatment
How many people
403 participants
Where
1 siteCanada
Study dates
20 Apr 2020to 30 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years or older
  • infant under 12 months old
  • EPDS score 10 or more
  • Fluent in written/spoken English

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • McMaster University

    Hamilton, Ontario, L8S 4L8

Other trials in Canada

About this study

Official title: Online 1-Day CBT-Based Workshops for Postpartum Depression

Postpartum depression (PPD) already affects up to 1 in 5 women and left untreated costs $150,000 per case over the lifespan. Under normal conditions, just 10% of women with PPD get evidence-based treatment, a situation that has worsened substantially during COVID-19. The purpose of this study is to a assess if self-referred, online adaptation of a 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop for PPD delivered up to 30 women at a time can lead to reductions in PPD, if the workshops are cost-effective, and to assess workshop impact on common complications of PPD (anxiety, partner relationship discord, problems with mother-infant attachment). 388 women will be randomized to receive either immediate treatment or treatment 12 weeks later (waitlist control). Study measures will be collected at baseline (immediately before treatment workshop) and 12 weeks later (immediately before wait list control workshop).

Read the detailed description

The COVID-19 pandemic has further exposed the vulnerabilities in social and economic systems that lead to inequalities for mothers with mental health problems and their children, worsening unintended systematic biases that exist within the healthcare system. These women have been among the most affected by the pandemic, experiencing substantial worry, isolation, loneliness, lack of control, and insomnia (1), all of which have increased PPD rates. They also have more responsibilities than ever before, providing care to their infants, toddlers, and older children, while managing their households and supporting their partners. They are also profoundly worried about job losses, reduced income, and food insecurity , all of which have disrupted family routines, increased partner conflict, and rates of intimate partner violence (2).

Postpartum depression (PPD) typically affects up to 1 in 5 women (3-5), increasing the risk of later depressive episodes (6), parenting problems (7), poor mother-infant attachment (8), and emotional, behavioural, and school problems in offspring (9,10). A single case of PPD has been estimated to cost as much as $150,000 over the lifespan (11), or $57 billion for each annual cohort of Canadian births. Even under ideal conditions, the healthcare system is poorly equipped to provide care for problems requiring urgent psychotherapy like PPD (e.g., just 1 in 10 women with PPD receive evidence-based care) (12). Barriers to care include women's preference for psychotherapy over medication, a lack of time, and a reluctance to travel to regular appointments (13,14). The healthcare system is now even less able to help these women as public health units that previously supported the mental health of mothers have shifted their priorities to direct COVID response. Moreover, social distancing recommendations aimed at reducing COVID-19 risk have inadvertently increased psychological distress and decreased access to resources that protect against PPD including social and practical support from family, friends, and professionals. The need for safe and accessible PPD treatment is further highlighted by the uptake of recent recommendations (written by the NPI) on managing PPD during COVID-19 which have been read 40,000 times since their posting (12).

Only interventions that are considered safe and that can be rapidly upscaled can have an impact on PPD at the population level during COVID-19 (15). Ideal large-scale interventions for PPD during COVID-19 are not only safe (i.e., delivered online), but are brief, utilize the treatments most preferred by women (i.e., non-pharmacological), easily accessible (i.e., self-referred), provide skills that can be used over the long-term, and delivered in large groups to increase social support. At present time, no interventions exist that meet all of these criteria.

The purpose of this study is to assess if Online 1-Day CBT-Based Workshops for PPD added to care as usual during the COVID-19 pandemic improve PPD more than usual care alone, if the workshops are cost-effective, and if these workshops reduce the impact of the common comorbidities and complications of PPD (anxiety, partner relationship discord, and poorer mother-infant attachment).

388 women who are 18 years or older, have a baby under 1 year old and have an Edinburgh Postnatal Depression Scale (EPDS) score of 10 or more will be randomized to receive either immediate treatment or treatment 12 weeks later (waitlist control) and changes in depression, anxiety, relationship quality, and mother-infant attachment will be compared.

PPD is a major public health issue that has only increased in scope and impact during COVID-19, and no safe, accessible, scalable solutions exist to tackle the scope of this problem. Only health system interventions like ours that utilize existing infrastructure from a previous RCT of face-to-face workshop delivery can be launched expediently on a large scale to significantly improve the health of Canadian women with PPD and their families during this pandemic.

Promising data from a face-to-face trial, and very encouraging recruitment and feasibility findings from the online adaptation of these workshops suggest that self-referred Online 1-Day CBT-Based Workshops can be delivered immediately and rapidly scaled to reduce the impact of COVID-19 on women with PPD and their families. Since the pandemic will have a lasting impact on the delivery of mental healthcare, these online workshops could represent a significant component of the next successfully implemented, research-enabled Canadian public health strategy, and will be applicable globally.

Being tested
Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop
Medical subject headings
Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online 1-Day Cognitive Behavioural Therapy (CBT)-Based WorkshopBehavioural

    The workshop is a day-long intervention delivered in 4 modules based on Cognitive Behavioural Therapy (CBT). The workshop covers PPD etiology, modifiable cognitive risk factors, cognitive skills, behavioural skills, problem solving, goal setting and action planning. Each participant is given a professionally designed manual to facilitate learning. Weekly reminder emails are sent for 6 weeks after the workshop completion to encourage practice. A list of PPD resources and a copy of the Canadian Treatment Guidelines for Postpartum Depression are provided.

Study groups in NCT04485000
Study groupRoleWhat they receive
Immediate TreatmentExperimentalThe experimental (immediate workshop) group will receive the online workshop at baseline (T1) in addition to receiving standard postnatal care.
Receives: Behavioral: Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop
Waitlist CpntrolOtherThe waitlist control group will receive standard postnatal care for 12 weeks and will participate in the online 1-day CBT-based workshop at T2 (12 weeks post baseline).
Receives: Behavioral: Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Edinburgh Postnatal Depression Scale (EPDS)

    The gold standard measure of PPD in clinical practice/research. Produces a score of 0-30, with higher scores indicating more severe depressive symptoms. A change of 4 points is recognized as a clinically meaningful/significant improvement.

    Measured: Differences between experimental and control groups from T1 (baseline) to T2 (12 weeks) will be compared.

Secondary outcomes (2)
  1. Cost-effectiveness: Costs of service

    Healthcare resource utilization data will be collected using a questionnaire based on the Canadian Community Health Survey and the Service Use and Resources Form adapted for the postpartum period and used in previous PPD research. Costs will be calculated using provincial or other standard billing rates.

    Measured: Resources consumed over the 12-week trial period from the perspective of public healthcare payer will be measured.

  2. Cost-effectiveness: Quality-Adjusted Life Year (QALY)

    The EQ-5D-5L, a utility-based health-related quality of life instrument will be used. Its validity in measuring the impact of depression is established. Its Canadian scoring algorithm will be used. For each participant, a QALY will be calculated by multiplying the health utility for the matching time period (i.e., the area under the curve approach).

    Measured: QALYs will be measured over the 12-week trial period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2020
  2. Study start20 Apr 2020
  3. Primary completion30 Jan 2021
  4. Study completion30 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
403 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04485000
Sponsor's protocol ID
ONLINE1DAYCBT
Status last verified
Feb 2021
First submitted
21 Jul 2020
Last updated
16 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • George KV, Savoy CD, Layton H, Bieling PJ, Van Lieshout RJ. Prevalence of Comorbid Postpartum Depression and Anxiety in Birthing Parents Seeking Treatment for Postpartum Depression: Prevalence de la presence comorbide de la depression et de l'anxiete post-partum chez les parents ayant accouche qui ont consulte en raison de la depression post-partum. Can J Psychiatry. 2026 Jul 1:7067437261462698. doi: 10.1177/07067437261462698. Online ahead of print.

    PubMed 42383885
  • Van Lieshout RJ, Layton H, Savoy CD, Brown JSL, Ferro MA, Streiner DL, Bieling PJ, Feller A, Hanna S. Effect of Online 1-Day Cognitive Behavioral Therapy-Based Workshops Plus Usual Care vs Usual Care Alone for Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Nov 1;78(11):1200-1207. doi: 10.1001/jamapsychiatry.2021.2488.

    PubMed 34495285
  • Layton H, Owais S, Savoy CD, Van Lieshout RJ. Depression, Anxiety, and Mother-Infant Bonding in Women Seeking Treatment for Postpartum Depression Before and During the COVID-19 Pandemic. J Clin Psychiatry. 2021 Jul 6;82(4):21m13874. doi: 10.4088/JCP.21m13874.

    PubMed 34232578

Questions about this trial

What is this clinical trial studying?

A study testing Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop in people with Postpartum Depression, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Edinburgh Postnatal Depression Scale (EPDS) (time frame: Differences between experimental and control groups from T1 (baseline) to T2 (12 weeks) will be compared.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04485000, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Online 1-Day CBT-Based Workshops for PPD (NCT04485000) | AzTrials